Isopto Carpine

Isopto Carpine (pilocarpine hydrochloride ophthalmic solution) is a cholinergic agonist prepared as a sterile topical ophthalmic solution.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension.

In the four clinical trials, patients were treated with Isopto Carpine 2%, two to four times daily or with pilocarpine 1%, 1.75% or 2% in fixed combination with betaxolol 0.25%, two or three times daily.

The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were:

• headache/browache,
• accommodative change,
• blurred vision,
• eye irritation,
• visual impairment (dim, dark, or “jumping” vision), and
• eye pain.

The adverse reaction profile reported for the use of Isopto Carpine in pediatric patients is comparable to that seen in adult patients.

Reduction of Elevated Intraocular Pressure (IOP) in Patients with Open-Angle Glaucoma or Ocular Hypertension

• One drop of Isopto Carpine 1%, 2% or 4% should be applied topically in the eye(s) up to four times daily.
• Pilocarpine-naïve patients should be started on the 1% concentration as higher concentrations are often not tolerated initially.
• The frequency of instillation and concentration of Isopto Carpine are determined by the severity of the elevated intraocular pressure and miotic response of the patient.
• To limit systemic exposure to pilocarpine, patients may be instructed to perform punctal occlusion for 2 minutes after instillation of Isopto Carpine ophthalmic solution.

Management of Acute Angle-Closure Glaucoma

• Prior to Isopto Carpine use, treatment with secretory suppressants and hyperosmotic agents may be needed to lower IOP below 50 mmHg and relieve iris ischemia.
• For initial management of acute angleclosure glaucoma, one drop of Isopto Carpine 1% or 2% may be applied topically in the eye(s) up to three times over a 30-minute period.
• If laser iridoplasty or iridomy is used to break the attack, one drop of Isopto Carpine 4% should be administered prior to the procedure. Following laser iridoplasty, one drop of Isopto Carpine 1% should be administered four times daily until an iridotomy can be performed.

Prevention of Postoperative Elevated IOP Associated with Laser Surgery

• One drop of Isopto Carpine 1%, 2% or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s) 15 to 60 minutes prior to surgery.

Induction of Miosis

• One drop of Isopto Carpine 1%, 2% or 4% (or two drops administered five minutes apart) should be applied topically in the eye(s).

Use with Other Topical Ophthalmic Medications

• Isopto Carpine may be used in combination with beta-blockers, carbonic anhydrase inhibitors, sympathomimetics or hyperosmotic agents.
• If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Use in Pediatric Patients

• In children under 2 years of age, one drop of Isopto Carpine 1% should be applied topically in the eye(s) three times daily.
• Children 2 years of age and over should be dosed as for adults.
• For the induction of miosis prior to goniotomy or trabeculotomy in children, one drop of Isopto Carpine 1% or 2% should be applied topically in the eye 15 to 60 minutes prior to surgery.

There is no information available on any drug interactions with Isopto Carpine.

• It is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isopto Carpine should be given to a pregnant woman only if clearly needed.
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Isopto Carpine is administered to a nursing woman.